F O R M U L A T I O N S

Ibuprofen 2% Topical Gel

It is practically insoluble in water but very soluble in alcohol
and acetone. 1

Rx
For 100 mL
Ibuprofen
Hydroxypropyl cellulose 1500 cps
Propylene glycol
Mineral oil, light
Alcohol USP
Puried water
qs

2g
1.5 g
10 mL
5 mL
75 mL
100 mL

METHOD OF PREPARATION
1. Calculate the required quantity of each ingredient for the
total amount to be prepared.
2. Accurately weigh and/or measure each ingredient.
3. Mix the ibuprofen and hydroxypropyl cellulose with the
propylene glycol.
4. Add the alcohol and mix well; it may take a while for the
mixture to become clear.
5. Add the mineral oil and mix well to disperse it as small
droplets.
6. Add sufficient puried water to volume and mix well.
7. Package and label.

PACKAGING
Package in tight, light-resistant containers. 1

LABELING
Keep out of reach of children. Use only as directed.

STABILITY
A beyond-use date of 30 days would be appropriate for this
preparation. 1

USE
Ibuprofen topical gel has been used in the treatment of sunburn and other minor painful irritations of the skin.

QUALITY CONTROL
Quality-control assessment can include theoretical weight
compared to actual weight, pH, specic gravity, active drug
assay, color, clarity, texture-surface, texture-spatula spread,
appearance, feel, rheological properties and physical observations. 2

DISCUSSION
Ibuprofen is a very effective nonsteroidal anti-inammatory
agent, used both orally and topically. This formulation can be
easily modied to alter the concentration of ibuprofen; the
mineral oil is included to provide a slight emollient effect so
the preparation is not as drying after application to the skin.
Ibuprofen (C 13 H 18 O 2 , MW 206.28) is a nonsteroidal anti-inammatory agent with analgesic and antipyretic activity. It is
used in the treatment of inammatory diseases (eg, rheumatoid
arthritis, juvenile arthritis, osteoarthritis) and pericarditis and
in the relief of mild-to-moderate pain. It occurs as a white to
off-white crystalline powder with a slight characteristic odor.

388

International Journal of Pharmaceutical Compounding

Vol. 8 No. 5 September/October 2004

Hydroxypropyl cellulose (cellulose, hydroxypropyl ether, Klucel,

Methocel, oxypropylated cellulose) is a white to slightly yellowcolored odorless and tasteless powder. It is widely used in
oral and topical pharmaceutical formulations. The pH of a
1% w/v aqueous solution is in the range of pH 5.08.5. It is
soluble 1 in 2 parts water, 1 in 2.5 parts ethanol and 1 in
5 parts propylene glycol, but practically insoluble in glycerin
and oils. 3
Propylene glycol (C 3 H 8 O 2 , MW 76.09) occurs as a clear,
colorless, viscous, practically odorless liquid with a sweet
taste, somewhat resembling glycerin. It is miscible with acetone, chloroform, 95% ethanol, glycerin and water. It is not
miscible with xed oils or light mineral oil. 4
Mineral oil, light is a transparent, colorless, viscous liquid that
is practically tasteless and odorless when cold; when warm, it
has a faint odor. It is used as an emollient, solvent, lubricant,
therapeutic agent and oleaginous vehicle. It has a specic gravity of 0.8180.880. It is insoluble in water or alcohol. It is miscible with volatile and xed oils, with the exception of castor
oil. To promote miscibility/solubilization, a small amount of a
suitable surfactant can be added. 5
Alcohol USP (C 2 H 5 OH, MW 46.07, ethyl alcohol, ethanol,
grain alcohol) is a clear, colorless mobile and volatile liquid
with a slight characteristic odor and a burning taste. It is used
as an antimicrobial preservative (>10% concentration), disinfectant (6090% concentration), as a solvent in injectable and
oral liquids (variable concentration), and as a solvent in topical
products (6090% concentration). Alcohol USP refers to 95%
ethanol, and dehydrated alcohol refers to 99.5% alcohol. Its
specic gravity is between 0.812 and 0.816 and its boiling
point is 78.15C. It is miscible with chloroform, glycerin and
water. 6

REFERENCES
1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 27National Formulary 22. Rockville, MD: US Pharmacopeial Convention,
Inc.; 2004: 953957, 23452349, 2766.
2. Allen LV Jr. Standard operating procedure for performing physical
quality assessment of ointments/creams/gels. IJPC 1998; 2: 308309.
3. Harwood RJ. Hydroxypropyl cellulose. In: Rowe RC, Sheskey PJ, Weller
PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington,
DC: American Pharmaceutical Association; 2003: 289293.
4. Weller PJ. Propylene glycol. In: Rowe RC, Sheskey PJ, Weller PJ, eds.
Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC:
American Pharmaceutical Association; 2003: 521523.
5. Abramowitz R, ODonoghue D. Light mineral oil. In: Rowe RC, Sheskey
PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed.
London: Pharmaceutical Press; 2003: 398399.
6. Owen SC. Alcohol. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook
of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 1315.